BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SACROFUSE

    MDR report key: 22554313 · Received July 21, 2025

    Report

    Report Number
    3005977257-2025-00003
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    May 30, 2025
    Report Date
    July 21, 2025
    Manufacturer
    LESSPINE INNOVATIONS
    Product Code
    LYP
    PMA / PMN Number
    K232605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING REVISIONS, BONY GROWTH GREATLY INCREASES THE TORQUE REQUIRED TO TURN THE SCREW. THE INSERTER TIPS CANNOT HANDLE THIS INCREASED FORCE AND, THEREFORE, BREAK OFF. THE INSERTER HAS BEEN REDESIGNED TO STRENGHTEN THE TEETH TO AVOID THIS IN THE FUTURE.

    Description of Event or Problem · 0

    A SURGERY TOOK PLACE IN WHICH A SACRIX INSERTER'S TIPS BROKE OFF. THIS IS LIKELY DUE TO A DOCTOR PERFORMING A REVISION AND ATTEMPTING TO USE THE INSERTER TO REMOVE THE SCREW THAT HAS BEEN SURROUNDED BY BONY GROWTH. THIS GROWTH INCREASES THE FORCE REQUIRED TO REMOVE THE SCREW AND RESULTED IN THE BREAKING OF THE TIPS. THIS DID NOT RESULT IN PATIENT HARM AND SURGERY WAS COMPLETED. DEBRIS THAT WAS EMBEDDED IN TISSUE WAS SAFELY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2752180 SACROFUSE IMPLANT INSERTER LYP LESSPINE INNOVATIONS 14-42003 HB12A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention